More From Guest Contributors


Guidelines To Bring Your Biologic To Market: Are You Prepared? Guidelines To Bring Your Biologic To Market: Are You Prepared?

Are you up to the task of bringing a biologic drug to market? Do you have a strategy and plan for moving forward? Here we explore, from a biopharma process development and manufacturing perspective, some of the questions to consider in order to map out a successful pathway and avoid pitfalls along the way.

ICH Q12 Updates: Increasing Predictability And Efficiency Of Post-Approval Changes ICH Q12 Updates: Increasing Predictability And Efficiency Of Post-Approval Changes

Through proper implementation of ICH Q12 tools and enablers, the industry could manage CMC changes effectively under a company’s pharmaceutical quality system with less need for extensive regulatory oversight prior to implementation.

Unlocking The Potential For Efficiency In Downstream Bioprocesses

In the bioprocessing industry, in order to make full use of upstream advances in an efficient manner, it is essential that downstream processes are intensified.

6 Regulatory Changes Affecting Bioprocessing In China

This article outlines six recent regulatory changes in China intended to protect patient safety as well as reduce regulatory burdens and minimize delays.

Improve Operational Efficiency In Biomanufacturing With Comprehensive Automation Solutions

This white paper outlines how connectivity and comprehensive automation solution can facilitate technology transfer and scaling from process development to final manufacturing scale.

A Common Sense Approach To Sustainability In The Biosimilar Business

Through common sense and creative thinking, the industry can discover new ways to achieve success and sustainability in the biosimilar market.

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What Is Quality By Design (QbD) – And Why Should You Care?

Proper implementation of QbD can potentially provide three main benefits for development.

Managing Risks Within Platform Processes Through Media Components
A platform process is a set of standardized protocols and reagents that can be used to support a variety of clinical molecules. An enhancement to the platform can be spread across multiple clinical molecules, improving an organization’s return on investment. By SAFC
Bioburden Entry Points In Downstream Processing

Tips to prevent bioburden entry and proliferation, and reduce the complexity of the equipment and processes involved.

Zero Margin For Error: The New Reality For Generic Pharmaceutical Manufacturers

Generic pharmaceutical manufacturers are facing a business dichotomy: The overall market for generic drugs is growing but at a slower pace as the number of branded drugs entering the market is shrinking, diminishing opportunities to capitalize on expiring patents. Consequently manufacturers face numerous challenges that can significantly impact operational efficiencies and revenue growth. 

Shifting and compacting markets, disappearing branded drug queues, economic pressures, and an influx of manufacturers entering the generic market are all contributing to shrinking individual revenue streams, causing many companies to map out new avenues to grow market share. The challenges are formidable, as generic manufacturers seek new products, business models, and more efficient business practices to overcome revenue-threating risks.

More Pharma Outsourcing App Notes & Case Studies


Outsourced Pharma provides comprehensive analysis and exclusive content from thought leaders for the advancement of global outsourcing of drug development and manufacturing. We offer readers of our website and participants of our conferences – our Outsourced Pharma community – a deeper exploration and understanding of the relationships between pharmaceutical and biotechnology organizations with their service providers, and an open channel of communication.

About Outsourced Pharma Conferences
Outsourced Pharma Conference & Exhibition is a vibrant forum for thought-leadership and the application of best practices for professionals engaged in outsourcing drug development and manufacturing. These conferences and exhibitions form a community for networking and discussing topics most relevant to sponsor-provider partnerships and supply-chain management, within an open format that promotes panel and attendee interaction.

About provides comprehensive analysis of global outsourcing, the biotechnology and pharmaceutical industries, and their intersection with the overall life sciences and healthcare markets. We offer readers a deeper exploration and understanding of the relationships between service providers and their bio and pharma sponsors.

Louis Garguilo Articles



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